Pembrolizumab + Chemotherapy for Thyroid and Salivary Gland Cancer

(iPRIME Trial)

Overseen By Cancer Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Must not be taking: Immunosuppressives, Steroids, others

Disqualifiers: Immunodeficiency, Active TB, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 39

Duration: 9-18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for individuals with difficult-to-treat thyroid or salivary gland cancers. It aims to determine if pembrolizumab, an immunotherapy that enhances the immune system's ability to fight cancer, combined with chemotherapy using docetaxel, can effectively manage these cancers. Participants will begin with both drugs and later continue with pembrolizumab alone for up to two years or until cancer progression. This trial may suit those with thyroid or salivary gland cancer that cannot be surgically removed or treated with standard therapies. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from a potentially effective new therapy.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or immunosuppressive therapy, you may need to adjust your treatment as these are part of the exclusion criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of pembrolizumab and chemotherapy, such as docetaxel, is generally well-tolerated. One study found that when pembrolizumab was used with chemotherapy, patients experienced manageable side effects, with most reactions being mild to moderate.

For pembrolizumab alone, studies in thyroid cancer patients have demonstrated a tolerable safety profile. Some patients may experience side effects, but these are usually not severe. Pembrolizumab has FDA approval for other cancers, indicating a known safety record.

Docetaxel, the chemotherapy component, is widely used in cancer care. It may cause common side effects like tiredness or nausea, but these are typically manageable.

Overall, while side effects can occur, research indicates the treatment is generally safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of pembrolizumab and chemotherapy for thyroid and salivary gland cancers because it offers a novel approach by using immunotherapy alongside traditional chemotherapy. Pembrolizumab, an immune checkpoint inhibitor, works by enhancing the body's immune response to target and destroy cancer cells, a mechanism not typically employed by standard treatments like surgery, radiation, or standalone chemotherapy. This dual approach could potentially lead to more effective treatment outcomes, especially for patients lacking a standard of care option. By activating the immune system while simultaneously attacking the cancer with chemotherapy, this treatment has the potential to provide a more comprehensive assault on the cancer cells.

What evidence suggests that this trial's treatments could be effective for thyroid and salivary gland cancer?

This trial will evaluate the combination of pembrolizumab and docetaxel for treating aggressive thyroid and salivary gland cancers. Studies have shown that pembrolizumab, when combined with chemotherapy like docetaxel, can help treat some difficult cancers. Research indicates that pembrolizumab, a type of immunotherapy, enables the body's immune system to attack cancer cells. Docetaxel, a chemotherapy drug, stops cancer cells from growing. Together, these drugs have shown promise in treating aggressive thyroid and salivary gland cancers. Early results suggest this combination may shrink tumors and slow disease progression. This approach has been especially beneficial for patients without other standard treatment options. ^{1 4 6 7 8}

Who Is on the Research Team?

Alexander Pearson

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

Adults with certain types of thyroid or salivary gland tumors that can't be removed by surgery or treated with curative intent. Participants must have a life expectancy over 12 weeks, good performance status, and acceptable organ function. Women of childbearing potential and men must agree to use contraception. Exclusions include recent participation in other trials, known allergies to trial drugs, active infections like TB or hepatitis, significant heart disease, autoimmune diseases requiring treatment within the past 2 years, untreated brain metastases, pregnancy/breastfeeding.

Inclusion Criteria

You are expected to live for more than 12 weeks.

I have a type of salivary gland cancer.

My thyroid cancer is resistant to radioiodine and hasn't responded well to certain therapies, or it's aggressive.

Exclusion Criteria

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

I have a history of lung inflammation not caused by infection.

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab and docetaxel every three weeks for 3 to 6 cycles

9-18 weeks

3-6 visits (in-person)

On-treatment Biopsy

For accessible tumors, patients receive an on-treatment biopsy at week three

1 week

1 visit (in-person)

Immunotherapy Maintenance

Participants receive pembrolizumab alone every three weeks until disease progression or up to 35 cycles

Up to 2 years

Up to 35 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Pembrolizumab

Trial Overview This Phase II trial tests Pembrolizumab (200mg IV every three weeks) combined with Docetaxel (75mg/m2 IV every three weeks) on patients with specific thyroid and salivary gland cancers. It's a single-arm study where all participants receive the same treatment regimen.

How Is the Trial Designed?

Group I: Cohort 2: 'aggressive' thyroid cancer without SOC treatment op Experimental Treatment 2 Interventions

All patients will receive pembrolizumab and docetaxel. First pembrolizumab and docetaxel will be given together. After which patients will receive pembrolizumab alone until disease progression or up to 35 cycles (about 2 years).

Group II: Cohort 1: salivary gland tumors without SOC treatment option Experimental Treatment 2 Interventions

All patients will receive pembrolizumab and docetaxel. First pembrolizumab and docetaxel will be given together. After which patients will receive pembrolizumab alone until disease progression or up to 35 cycles (about 2 years).

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03360890

Pembrolizumab With Chemotherapy for Poorly Chemo ... Pembrolizumab will be given every three weeks until disease progression or up to 35 cycles (about 2 years). Official Title. Synergy of Pembrolizumab Anti-PD-1 ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.15_suppl.TPS6099

A phase II study of pembrolizumab and docetaxel for ... A phase II study of pembrolizumab and docetaxel for aggressive RAI refractory thyroid carcinomas or salivary gland cancers: The iPRIME study.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12301719/

Remarkable Response to Chemo-immunotherapy In ... First effectiveness data of lenvatinib and pembrolizumab ... Boosted abscopal effect from radiotherapy and pembrolizumab in anaplastic thyroid ...

4. mdpi.com mdpi.com/2072-6694/16/6/1205

Exploring Immunological Effects and Novel Immune ... NCT 03360890 is a phase II single-arm clinical trial investigating the clinical efficacy of pembrolizumab combined with docetaxel in SGCs and thyroid cancer.

5. cda-amc.ca cda-amc.ca/sites/default/files/DRR/2025/PC0377-Keytruda_Combined_Review.pdf

Pembrolizumab (Keytruda) (e.g., adrenal gland, salivary gland, and thyroid cancers). If pembrolizumab ... Further collection of long-term data on efficacy and safety outcomes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36748723/

Efficacy and safety of pembrolizumab monotherapy in ... Pembrolizumab demonstrated manageable toxicity and durable antitumor activity in a small subset of patients with advanced thyroid cancer.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/125514s096lbl.pdf

Keytruda - accessdata.fda.gov Safety data are available for the first 203 patients who received KEYTRUDA and chemotherapy (n=101) or placebo and chemotherapy (n=102). Patients with ...

8. es.aetna.com es.aetna.com/cpb/medical/data/800_899/0890.html

Pembrolizumab (Keytruda) - Medical Clinical Policy Bulletins The authors note that limited data on advanced salivary gland carcinoma and SDC response to anti-PD-1 monotherapy indicate a low response rate (11% with ...